Add to ORKGABSTRACT – PURPOSE. The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of bioequivalence. In this study, both visual and chromametric assessments have been carried out on two topical creams containing clobetasol propionate (0.05%) and the results from both methods are compared. METHODS. Human subjects (volunteers) were screened using a cream containing 0.05% clobetasol propionate, in order to identify appropriate subjects for inclusion in the study. The study was implemented according to the FDA guidance using both visual and chromamete
The American FDA has recently released a Guidance document for topical corticosteroid bioequivalence...
The specialised nature of the stratum corneum makes it an efficient barrier to foreign substances, i...
In a recent Guidance document the American FDA recommended the use of a chromameterrather thanthe hu...
PURPOSE. The assessment of the degree of skin blanching following the application of a formulation...
Currently, clinical trials in patients are required by most regulatory authorities for the assessmen...
ABSTRACT – Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivale...
Numerous experiments in recent years have indicated differences in the bioavailability of corticoste...
In a Guidance document, the American FDA recommends the use of a Minolta chromameter rather than the...
The use of a portable noninvasive colorimeter is evaluated in the present studies for its ability to...
The potencies of topical corticosteroid products have mainly been classified using clinical data but...
Purpose. One of the unresolved issues in the FDA Guidance document for topical corticosteroid bioequ...
The human skin blanching assay is a well established method for ranking the efficacy of corticostero...
The human skin-blanching (or vasoconstrictor) assay has evolved from initial observations that corti...
The human skin blanching assay remains in widespread use as a reliable, qualitative, comparative ind...
human skin blanching assay for in vivo topical corticosteroid assessment II. Subject
The American FDA has recently released a Guidance document for topical corticosteroid bioequivalence...
The specialised nature of the stratum corneum makes it an efficient barrier to foreign substances, i...
In a recent Guidance document the American FDA recommended the use of a chromameterrather thanthe hu...
PURPOSE. The assessment of the degree of skin blanching following the application of a formulation...
Currently, clinical trials in patients are required by most regulatory authorities for the assessmen...
ABSTRACT – Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivale...
Numerous experiments in recent years have indicated differences in the bioavailability of corticoste...
In a Guidance document, the American FDA recommends the use of a Minolta chromameter rather than the...
The use of a portable noninvasive colorimeter is evaluated in the present studies for its ability to...
The potencies of topical corticosteroid products have mainly been classified using clinical data but...
Purpose. One of the unresolved issues in the FDA Guidance document for topical corticosteroid bioequ...
The human skin blanching assay is a well established method for ranking the efficacy of corticostero...
The human skin-blanching (or vasoconstrictor) assay has evolved from initial observations that corti...
The human skin blanching assay remains in widespread use as a reliable, qualitative, comparative ind...
human skin blanching assay for in vivo topical corticosteroid assessment II. Subject
The American FDA has recently released a Guidance document for topical corticosteroid bioequivalence...
The specialised nature of the stratum corneum makes it an efficient barrier to foreign substances, i...
In a recent Guidance document the American FDA recommended the use of a chromameterrather thanthe hu...